MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER 20G, 10CM W/ BASIC TRAY; INTRAVASCULAR CATHETER

Catalog Number	M120100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
On 11/7/2016- per sales representative the facility reported, when the product was initially taken out of the package, the wire felt a little stiff, as if caught on something but then after advanced fine and clinician was able to move forward to access the patient.It was stated that when the clinician advanced the needle, (clearly visualized with ultrasound) and ¿everything seemed normal¿.When the wire was being advanced the clinician stated that something did not feel right, similar to how it might feel if the needle was not in the vessel.The clinician reportedly, stopped the procedure with needle and wire fully deployed inside of vessel.When retracting entire device, the needle came out however the wire was stuck inside of the patient.It was reported that the wire was still connected to the device so the clinician did not move the device any further and called ir to help with retracting wire.Ir pa was able to maneuver the wire and safely pulled the wire out of the patient.Pa commented that the wire did not appear to be in the vessel, suspect maybe in the soft tissue.When viewing the device/wire, it was stated that the main wire remained straight but the coiled wire was extended and bent.Patient was sent to x-ray and confirmed no wire was left in the body.Pa discarded the device and packaging was thrown away.No harm to patient was reported.

• Brand Name: POWERGLIDE MIDLINE CATHETER 20G, 10CM W/ BASIC TRAY
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6115310
• Report Number: 3006260740-2016-00617
• Device Sequence Number: 224476
• Product Code: FOZ
• UDI-Device Identifier: 00801741075322
• UDI-Public: (01)00801741075322
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K121073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M120100
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1